Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune

The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity). An observation period of about 10 years extends far beyond the duration of clinical trials. First and foremost are questions about tolerability and the efficacy of an antiretroviral combination treatment with Viramune and other antiretroviral partners. In particular, adverse events will be recorded and the therapeutic effect will be monitored via the course of viral load and improvement of the immune system, based on the CD4 cell count.

Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune

Change in log10 Viral Load From Baseline to Last Visit [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ] [ Designated as safety issue: No ]

Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.

Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit [ Time Frame: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ] [ Designated as safety issue: No ]

Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ] [ Designated as safety issue: No ]

Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.

Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ] [ Designated as safety issue: No ]

Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.

Secondary Outcome Measures:

Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade [ Time Frame: Up to 185 months ] [ Designated as safety issue: No ]

Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade [ Time Frame: Up to 185 months ] [ Designated as safety issue: No ]

Inclusion criteria The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC (R08-0843)

Exclusion criteria The exclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC (R08-0843).

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979420